US 12,420,003 B2
Endovascular device for dysfunctional fistulas
Antonio Salsano, Chieti (IT); and Giancarlo Salsano, Chieti (IT)
Appl. No. 17/422,472
Filed by Antonio Salsano, Chieti (IT); and Giancarlo Salsano, Chieti (IT)
PCT Filed Jan. 22, 2020, PCT No. PCT/IB2020/050496
§ 371(c)(1), (2) Date Jul. 13, 2021,
PCT Pub. No. WO2020/152600, PCT Pub. Date Jul. 30, 2020.
Claims priority of application No. 102019000000981 (IT), filed on Jan. 23, 2019.
Prior Publication US 2022/0088283 A1, Mar. 24, 2022
Int. Cl. A61M 1/36 (2006.01)
CPC A61M 1/3655 (2013.01) 12 Claims
OG exemplary drawing
 
1. An endovascular device (1) for dysfunctional dialysis surgical fistulas, comprising:
a first tubular sheath (3);
a second tubular sheath comprising a fibrous layer (5) made of a fibrous material containing a coherent set of fibers, wherein the second tubular sheath includes two lateral ends, and the second tubular sheath is enclosed in entirety, by the first tubular sheath (3);
a third tubular sheath (9) enclosed, in entirety, by the second tubular sheath, wherein a thickness of the third tubular sheath (9) is same as a thickness of the first tubular sheath (3),
at least two expansion sections (7A, 7B), wherein each expansion section (7A, 7B) of the at least two expansion sections (7A, 7B) comprise an expander device (70) arranged to radially expand the endovascular device (1) at least in correspondence with the respective expansion sections (7A, 7B), wherein
the expander device (70) positioned at each end of the endovascular device (1) is disposed inside the fibrous layer (5),
the expander device (70) includes a first end and a second end,
said endovascular device (1) forms two ends and comprises an intermediate section (11) which extends between the two ends of the endovascular device (1) and is devoid of the expander device (70) and others metal bodies, so that the intermediate section (11) closes or tends to repeatedly close holes produced by a needle for haemodialysis treatments, each of the fibrous layer (5), the first tubular sheath (3), and the third tubular sheath (9) extends at least in correspondence with said intermediate section (11), the fibrous layer (5), in correspondence with the intermediate section (11), is prickable and able to close and reseal quickly, and the intermediate section (11) maintains a shape optimal for quick resealing of the holes after puncture, wherein
the intermediate section includes a tapered portion and a non-tapered portion, the tapered portion includes a periphery, a thickness of the fibrous layer (5) in the non-tapered portion is greater than a thickness of the fibrous (5) in the periphery of the tapered portion, and the thickness of the fibrous layer (5) in the periphery is greater than a thickness of the fibrous layer (5) in each of the expansion section (7A, 7B),
the first end of the expander device (70) is towards the intermediate section, the second end of the expander device (70) is at both lateral ends of second tubular sheath,
said fibrous layer (5) endothelized after a time period,
an internal diameter (DINT11) of the expander device (70) across an entire cross-section, at the intermediate section (11) is smaller than an internal diameter (DINT7) of the expander device (70) at each of the expansion section (7A, 7B), and
said endovascular device (1) being a device for the treatment of the dysfunctional surgical fistulas, adapted to be inserted inside the dysfunctional surgical fistula, when the endovascular device begins to shrink or occlude after a certain number of punctures, to keep the endovascular device pervious, increasing the survival of the dialysis fistulas;
a first set of markers (80) between the intermediate section (11) and the at least two expansion sections (7A, 7B), and
a second set of markers (82) wherein a first marker of the second set of markers (82) is at the first end of the expander device (70) and a second marker of the second set of markers (82) is externally adjacent to the second end of the expander device (70), wherein a shape of the first set of markers (80) is same as a shape of the second set of markers (82).